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Disitamab Vedotin for injection
Disitamab Vedotin for injection is a Monoclonal antibody-drug conjugate Small molecule drug developed by RemeGen Co., Ltd.. It is currently in Phase 2 development for Locally advanced or metastatic non-small cell lung cancer. Also known as: RC48.
Disitamab vedotin is a monoclonal antibody-drug conjugate that targets the epidermal growth factor receptor (EGFR) and delivers a microtubule inhibitor to cancer cells.
Disitamab vedotin is a monoclonal antibody-drug conjugate that targets the epidermal growth factor receptor (EGFR) and delivers a microtubule inhibitor to cancer cells. Used for Locally advanced or metastatic non-small cell lung cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Disitamab Vedotin for injection |
|---|---|
| Also known as | RC48 |
| Sponsor | RemeGen Co., Ltd. |
| Drug class | Monoclonal antibody-drug conjugate |
| Target | EGFR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
The antibody component of disitamab vedotin binds to EGFR on the surface of cancer cells, while the microtubule inhibitor component interferes with cell division, leading to cell death. This mechanism is particularly effective against EGFR-expressing tumors.
Approved indications
- Locally advanced or metastatic non-small cell lung cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Anemia
- Thrombocytopenia
- Neutropenia
- Anorexia
- Weight loss
Key clinical trials
- DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer (PHASE2)
- A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection (PHASE2)
- RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients (PHASE2)
- Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (PHASE1, PHASE2)
- Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer (PHASE2)
- RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure (PHASE1, PHASE2)
- To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 (PHASE1, PHASE2)
- To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Disitamab Vedotin for injection CI brief — competitive landscape report
- Disitamab Vedotin for injection updates RSS · CI watch RSS
- RemeGen Co., Ltd. portfolio CI
Frequently asked questions about Disitamab Vedotin for injection
What is Disitamab Vedotin for injection?
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Related
- Drug class: All Monoclonal antibody-drug conjugate drugs
- Target: All drugs targeting EGFR
- Manufacturer: RemeGen Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Locally advanced or metastatic non-small cell lung cancer
- Also known as: RC48
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing